CYCLO-PROGYNOVA 2MG

Active substance: OESTRADIOL VALERATE

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Patient Information Leaflet

Cyclo-Progynova 2 mg
®

Estradiol valerate and norgestrel

Read all of this leaflet carefully before you start
taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your
doctor or pharmacist.

This medicine has been prescribed for you. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.

In this leaflet, Cyclo-Progynova 2 mg will be
called Cyclo-Progynova.
Information in this leaflet can be found by
looking under the following sections:
1.
What Cyclo-Progynova is for
1.1 Cyclo-Progynova is used for
2.
Before you take Cyclo-Progynova
2.1 Do not take Cyclo-Progynova if
2.2 Check with your doctor before taking CycloProgynova if
2.3 Safety of HRT
2.4 Heart disease
2.5 Stroke
2.6 Blood clots
2.7 Surgery (Surgical operations)
2.8 Breast cancer
2.9 Endometrial cancer
2.10 Ovarian cancer
2.11 Dementia
2.12 Tell your doctor if you are taking any of the
following medicines
2.13 Contraception
2.14 Pregnancy and breast-feeding
2.15 Driving and using machines
2.16 Warning about sugar intolerance
3.
How to take Cyclo-Progynova
3.1 When to start taking your medicine for the first
time
3.2 How to use the medicine
3.3 Medical check-ups
3.4 What bleeding pattern to expect with CycloProgynova
3.5 If you take more Cyclo-Progynova than you
should
3.6 If you forget to take Cyclo-Progynova
4.
Possible side effects
5.
How to store Cyclo-Progynova
6.
Further information.
6.1 What Cyclo-Progynova contains
6.2 What Cyclo-Progynova looks like
6.3 Marketing Authorisation Holder
6.4 Manufacturer
1. What Cyclo-Progynova is for
Cyclo-Progynova belongs to a group of medicines
called hormone replacement therapy (HRT).
Cyclo-Progynova contains two hormones called
estradiol (an oestrogen) and norgestrel (a
progestogen). These act in different ways in your
body.
During the menopause (sometimes called “the
change of life”) a woman’s body slowly produces
less oestrogen. This may cause hot flushes, night
sweats, mood swings and dryness in the vagina.
Over a long time it may also cause a thinning of the
bones, which may be more likely to then break
(osteoporosis).
Cyclo-Progynova works by replacing the oestrogen
you lose during the menopause and therefore
improves the unpleasant symptoms you may get.
Oestrogen can also make the lining of your womb
grow more than usual, which may lead to cancer
developing there. The other hormone in CycloProgynova called a progestogen reduces the
chance of getting cancer of the womb.
1.1 Cyclo-Progynova is used for:

Treating symptoms of the menopause. This
includes hot flushes, night sweats, mood
swings and dryness in the vagina

Preventing thinning of the bones (osteoporosis)
in women who are not allowed to take other
types of medicines to prevent this from
happening
There are some small risks with taking HRT and you
should discuss this with your doctor before you
start taking Cyclo-Progynova (also see Section 2).
2. Before you take Cyclo-Progynova
2.1 Do not take Cyclo-Progynova if you have, or
have ever had:

An allergic reaction to estradiol or norgestrel

An allergic reaction to any of the other
ingredients of Cyclo-Progynova (listed in
section 6)

Breast or womb cancer

Bleeding from your vagina and the cause is not
known

Endometrial hyperplasia that is not being
treated (an overgrowth of the lining of the
womb)

Blood clots in a vein in your leg (deep vein
thrombosis or DVT) or in your lungs (pulmonary
embolus) or any other problems with blood
clots forming.

if you have a high risk of venous or arterial
thrombosis (blood clot)

Angina, a stroke or other heart disease

Liver problems

Kidney problems

Porphyria (a rare blood disorder).
If any of the above applies to you, do not take
Cyclo-Progynova and talk to your doctor or
pharmacist.
2.2 Check with your doctor before taking CycloProgynova if you have, or have ever had any of
the following:

Uterine fibroids (lumps of fibrous and muscular
tissue in your womb)

Endometriosis (where tissue from the womb is
found outside the womb)

Endometrial hyperplasia (overgrowth of the
lining of the womb)

Risk factors for cancer, such as history of the
disease in your family

Risk factors for blood clotting problems

Risk factors for angina, a stroke or heart
disease

You have elevated levels of triglycerides
(special type of blood lipids)

chloasma (patches of discoloration on the skin)

High blood pressure

Diabetes

Gallstones

Adenoma of the anterior lobe of the pituitary
gland (pituitary adenoma)

Migraine or severe headache

Systemic lupus erythematosus, (SLE or lupus
for short)

Epilepsy

Asthma

Otosclerosis (hearing loss due to a problem
with the bones in the ear).

A condition known as hereditary angioedema
(see section 4).

Chorea minor

Premature menopause
2.3 Safety of HRT
As well as benefits, HRT has some risks which
you may wish to discuss with your doctor when
you are deciding whether to start HRT, or whether
to carry on taking it.
Effects on your heart or circulation
2.4 Heart disease
HRT is not recommended for women who
have or have recently had heart disease. If you
have ever had heart disease, talk to your doctor
to see if you should be taking HRT.
HRT will not help to prevent heart disease.
Studies with one type of HRT (containing
conjugated oestrogen plus the progestogen MPA)
have shown that women may be slightly more
likely to get heart disease during the first year of
taking the medication. For other types of HRT, the
risk is likely to be similar, although this is not yet
certain.

If you get:
A pain in your chest that spreads to your arm
or neck.
See a doctor as soon as possible and do not
take any more HRT until your doctor says you
can. This pain could be a sign of heart disease.
2.5 Stroke
Recent research suggests that HRT slightly
increases the risk of having a stroke. Other things
that can increase the risk of stroke include:

Getting older

High blood pressure

Smoking

Drinking too much alcohol

An irregular heartbeat.
If you are worried about any of these things, or
if you have had a stroke in the past, talk to your
doctor to see if you should take HRT.
Compare:
Looking at women in their 50s who are not
taking HRT — on average, over a 5-year
period, 3 in 1000 would be expected to have
a stroke.
For women in their 50s who are taking HRT,
the figure would be 4 in 1000.
Looking at women in their 60s who are not
taking HRT — on average, over a 5-year
period, 11 in 1000 would be expected to
have a stroke.
For women in their 60s who are taking HRT,
the figure would be 15 in 1000.
If you get:
Unexplained migraine-type headaches, with
or without disturbed vision.
See a doctor as soon as possible and do not
take any more HRT until your doctor says you
can. These headaches may be an early warning
sign of a stroke.
2.6 Blood clots
HRT may increase the risk of blood clots in the
veins (also called deep vein thrombosis, or
DVT), especially during the first year of taking it.
These blood clots are not always serious, but if
one travels to the lungs, it can cause chest pain,
breathlessness, collapse or even death. This
condition is called pulmonary embolism, or PE.
DVT and PE are examples of a condition called
venous thromboembolism, or VTE.
You are more likely to get a blood clot if:

You are seriously overweight

You have had a blood clot before

Any of your close family have had blood clots

You have had one or more miscarriages

You have any blood clotting problem that
needs treatment with a medicine such as
warfarin

You’re off your feet for a long time because
of major surgery, injury or illness

You have a rare condition called SLE (see
Section 2).
If any of these things apply to you, talk to your
doctor to see if you should take HRT. Your doctor
will discuss with you the benefits and risks of
Cyclo-Progynova. She/he will check, e.g. whether
you have a higher risk of getting a thrombosis due
to a combination of risk factors or perhaps one
very strong risk factor. In the case of a combination
of factors the risk may be higher than simply
adding two individual risks. If the risk is too high,
your doctor will not prescribe HRT treatment.
Compare:
Looking at women in their 50s who are not
taking HRT — on average, over a 5-year
period, 3 in 1000 would be expected to get a
blood clot.
For women in their 50s who are taking HRT,
the figure would be 7 in 1000.
Looking at women in their 60s who are not
taking HRT — on average, over a 5-year
period, 8 in 1000 would be expected to get a
blood clot.
For women in their 60s who are taking HRT,
the figure would be 17 in 1000.
If you get:

painful swelling in your leg

sudden chest pain

difficulty breathing.
You must see a doctor as soon as possible
and do not take any more HRT until your
doctor says you can. These may be signs of a
blood clot
2.7 Surgery (Surgical operations)
If you’re going to have surgery, make sure your
doctor knows about it. You may need to stop
taking HRT about 4 to 6 weeks before the
operation, to reduce the risk of a blood clot. Your
doctor will tell you when you can start taking HRT
again.
Effects on your risk of developing cancer
2.8 Breast cancer
Women who have breast cancer, or have had
breast cancer in the past, should not take HRT.
Taking HRT slightly increases the risk of breast
cancer; so does having a later menopause,
alcohol intake and adiposity. The risk for a postmenopausal woman taking oestrogen-only HRT
for 5 years is about the same as for a woman of
the same age who is still having periods over that
time and not taking HRT. The risk for a woman
who is taking oestrogen plus progestogen HRT is
higher than for oestrogen-only HRT (but oestrogen
plus progestogen HRT is beneficial for the
endometrium, see ‘Endometrial cancer’ below).
For all kinds of HRT, the extra risk of breast cancer
goes up the longer you take it, but returns to
normal within about 5 years after stopping HRT.
Your risk of breast cancer is also higher if you:

Have a close relative (mother, sister or
grandmother) who has had breast cancer

are seriously overweight.
Compare:
Looking at women aged 50 who are not
taking HRT — on average, 32 in 1000 will be
diagnosed with breast cancer by the time
they reach the age of 65.
For women who start taking oestrogen-only
HRT at age 50 and take it for 5 years, the
figure will be 33 and 34 in 1000 (i.e. an extra
1-2 cases).
If they take oestrogen-only HRT for 10 years,
the figure will be 37 in 1000 (i.e. an extra 5
cases).
For women who start taking oestrogen plus
progestogen HRT at age 50 and take it for 5
years, the figure will be 38 in 1000 (i.e. an
extra 6 cases).
If they take oestrogen plus progestogen HRT
for 10 years, the figure will be 51 in 1000 (i.e.
an extra 19 cases).
If you notice any changes in your breast,
such as:

dimpling of the skin

changes in the nipple

any lumps you can see or feel
Make an appointment to see your doctor as
soon as possible.
2.9 Endometrial cancer (cancer of the lining
of the womb)
Taking oestrogen-only HRT for a long time can
increase the risk of cancer of the lining of the
womb (the endometrium). Taking a progestogen
as well as the oestrogen helps to lower the extra
risk.
If you still have your womb, your doctor will
usually prescribe a progestogen as well as
oestrogen. These may be prescribed separately,
or as a combined HRT product.
If you have had your womb removed (a
hysterectomy), your doctor will discuss with you
whether you can safely take oestrogen without a
progestogen.
If you’ve had your womb removed because of
endometriosis, any endometrium left in your
body may be at risk. So your doctor may prescribe
HRT that includes a progestogen as well as an
oestrogen.

Your product, Cyclo-Progynova contains a
progestogen.
Compare
Looking at women who still have a uterus
and who are not taking HRT – on average 5
in 1000 will be diagnosed with endometrial
cancer between the ages of 50 and 65.
For women who take oestrogen-only HRT,
the number will be 2 to 12 times higher,
depending on the dose and how long you
take it.
The addition of a progestogen to oestrogenonly HRT substantially reduces the risk of
endometrial cancer.
If you get breakthrough bleeding or spotting,
it’s usually nothing to worry about, especially
during the first few months of taking HRT.
If the bleeding or spotting:

carries on for more than the first few
months

starts after you’ve been on HRT for a
while

carries on even after you’ve stopped
taking HRT.
You must make an appointment to see your
doctor. It could be a sign that your endometrium
has become thicker.
2.10 Ovarian cancer
Ovarian cancer (cancer of the ovaries) is very rare,
but it is serious. It can be difficult to diagnose,
because there are often no obvious signs of the
disease.
Some studies have indicated that taking
oestrogen-only HRT for more than 5 years may
increase the risk of ovarian cancer. It is not yet
known whether other kinds of HRT increase the
risk in the same way.
2.11 Dementia
HRT will not prevent memory loss. In one study of
women who started using combined HRT after
the age of 65, a small increase in the risk of
dementia was observed.
2.12 Liver tumor
During or after the use of hormones such as those
that are contained in Cyclo-Progynova, benign liver
tumors have rarely occurred, and malignant liver
tumors even more rarely. In isolated cases, bleeding
from such tumors into the abdominal cavity has
endangered life. Although such events are extremely
improbable you should inform your doctor about
any unusual feelings in your upper abdomen that do
not disappear within a short time.
2.13 Tell your doctor if you are taking any of the
following medicines:

Anticonvulsants such as phenobarbital or
phenytoin (to treat epilepsy)

Antibiotics such as rifampicin or rifabutin (to
treat infections)

Herbal medicines containing the herb St.
John’s Wort

Insulin or other medicines to treat diabetes

Protease inhibitors (to treat HIV)

Transcriptase inhibitors such as nevirapine or
efavirenz (to treat HIV)

Any other medicine, including medicines
obtained without a prescription.
2.14 Contraception
This medicine will not act as a contraceptive.
Ask your doctor for advice if you are already using
a contraceptive. This medicine may interfere with it.
2.15 Pregnancy and breast-feeding
Do not take Cyclo-Progynova if you are pregnant or
breast-feeding.
If you become pregnant whilst taking this medicine,
you must immediately stop taking this medicine
and ask your doctor for advice.
2.16 Driving and using machines
Whilst taking Cyclo-Progynova you may feel dizzy.
If this happens, do not drive or operate machinery.
2.17 Warning about sugar intolerance
This medicine contains sugar. If you have been told
by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this
medicine.
3. How to take Cyclo-Progynova
Always take Cyclo-Progynova exactly as your
doctor has told you.
Important:
Your doctor will choose the dose that is right for
you. Your dose will be shown clearly on the label
that your pharmacist puts on your medicine. If it
does not, or you are not sure, ask your doctor or
pharmacist.
3.1 When to start taking your medicine for the
first time
Depending on your situation you should start to
take this medicine at the following times of the
month:

If you are having regular periods, start taking
the medicine on the fifth day of your period.

If you are not having regular periods, you can
start at any time.

If you are changing from another HRT medicine
that gives you a period complete the treatment
course of the other medicine. Then on the next
day start to take this medicine.

If you are changing from another HRT medicine
that does not give you a period, you can start
at any time.
3.2 How to use the medicine

Your pack contains 1 foil memo-strip and
7  blue stickers showing days of the week.
Each blue sticker starts with a different day of
the week.

Peel off a strip that starts with your starting
day. Stick this sticker along the top of the foil
memostrip where it states ‘fix the blue sticker
here’ so that the first day is above the pill
marked ‘start’.

You can now see on which days you have to
take each tablet. Take one tablet each day,
following the direction of the arrows, until you
have finished all 21 tablets.

Swallow the tablets whole with water. Do not
chew the tablets.

Take the tablets at the same time every day.

After day 21 you will have a 7 day tablet free
break. During this week, bleeding similar to a
period may occur. This is normal.

Start the next strip immediately after the 7 day
break. You will start your new strip of tablets on
the same day of each month. Take the tablets
even if your bleeding has not finished.
If you are not sure how to use the sticker and the
memo-pack then please ask your pharmacist for
advice.
3.3 Medical check-ups
Once you are taking this medicine:

Regularly check your breasts for any changes.
If you notice dimpling of the skin, changes
in the nipple, or any lumps you must see
your doctor as soon as possible.

Go for regular breast screening

Go for regular cervical smear tests

See your doctor for regular check-ups (at least
once a year). At these check-ups, your doctor
will discuss with you the benefits and risks of
continuing to take HRT.
3.4 What bleeding pattern to expect with CycloProgynova
As with normal periods, the amount of blood loss
will vary from woman to woman.
Your bleeding pattern may change when you are
taking this medicine. You may have:

Bleeding in the first three weeks of starting the
tablets. If so, ask your doctor for advice.

Heavier bleeding. You may notice this more if
your periods have become short or lighter
before you started treatment. This is normal.

Bleeding in the break where you take no
tablets. This is normal.
If after several months you are still getting
spotting or breakthrough bleeding, or you are
worried about your bleeding you must see your
doctor.
3.5 If you take more Cyclo-Progynova than you
should
If you accidentally take too much of your medicine,
immediately tell your doctor or go to the nearest
hospital casualty department.

3.6 If you forget to take Cyclo-Progynova

If your tablet is less than 12 hours late, take the
tablet as soon as possible, then take your next
tablet at the normal time.

If your tablet is more than 12 hours late, leave
the forgotten tablet in the pack, and take your
next tablet at the normal time.

You may get some vaginal bleeding
(breakthrough bleeding) if you have missed a
tablet. This is normal.
If you have any further questions about the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Cyclo-Progynova can cause side
effects, although not everybody gets them.
If you have any of the following symptoms:

Chest pain that spreads to your arm or
neck

Sudden numbness or confusion

Difficulty breathing

Severe rash that might blister

Sudden pain and swelling in your leg

You notice yellowing of your skin or eyes

Severe or prolonged headache, possibly
with disturbed vision for the first time.
Seek immediate medical help and stop
taking Cyclo-Progynova.
If you get any of the following symptoms:

If you notice any changes in your breast
such as a lump, dimpling in the skin or
the nipple changing

If bleeding or spotting carries on for
more than the first few months, or starts
after you have been taking the tablets for
a while

If bleeding or spotting carries on even
after you’ve stopped taking HRT.
See your doctor as soon as possible.
Important: All the symptoms in the boxes above
are signs that you may be developing a serious
problem. If you ignore these symptoms they may
become worse.
Other possible side effects
The following symptoms, which may or may not
have been caused by hormone replacement
therapy, and which in some cases were probably
symptoms of the climacteric, have been reported in
users of different oral hormone replacement therapy
preparations:
Common undesirable effects (between 1 and 10
in every 100 users may be affected)

weight loss or gain

Headache

stomach pain, nausea

rash, itching

vaginal bleeding including Spotting (bleeding
irregularities usually subside during continued
treatment)
Uncommon undesirable effects (between 1 and
10 persons in every 1,000 users may be affected)

allergies (hypersensitivity reaction)

depressed mood

dizziness

visual disturbances

palpitations(irregular, rapid beating or pulsation
of the heart)

dyspepsia (indigestion)

erythema nodosum (reddish painful nodules),

urticaria (hives)

breast pain, breast tenderness

edema(swelling due to excessive fluid
retention)
Rare undesirable effects (between 1 and 10 in
every 10,000 users may be affected)

anxiety, libido decreased or libido increased
(an increase or a decreased interest in sex)

migraine

contact lens intolerance

bloating, vomiting

hirsutism (excessive hair growth), acne

muscle cramps

dysmenorrhea
(painful
period),
vaginal
discharge,
Pre-menstrual-like
syndrome,
swollen breast

fatigue
In women with episodes of swelling in body parts
such as hands, feet, face, airway passages that are
caused by a defect in the gene that controls a blood
protein called C1-inhibitor (hereditary angioedema)
the hormone estradiol valerate in Cyclo-Progynova
may induce or exacerbate symptoms of hereditary
angioedema.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. How to store Cyclo-Progynova
Keep out of the reach and sight of children.
Do not use Cyclo-Progynova after the expiry date
on the carton. The expiry date refers to the last day
of that month.
Medicines should not be disposed of via wastewater
or household waste. Return any medicine you no
longer need to your pharmacist.
6. Further information
6.1 What Cyclo-Progynova contains

There are two active substances in this
medicine. the white tablets contain 2mg of
estradiol valerate. The pale-brown tablets
contain 2 mg of estradiol valerate and 0.5 mg
of norgestrel.

The other ingredients are lactose, maize starch,
povidone, talc, magnesium stearate (E572),
sucrose,
calcium
carbonate
(E170),
polyethylene glycol 6000.
The white tablets also contain titanium dioxide
(E171), yellow ferric oxide (E172) and red brown
ferric oxide (E172)
The pale-brown tablets also contain glycerin and
montan glycol wax.
6.2 What Cyclo-Progynova looks like
Cyclo-Progynova is made up of white and pale
brown tablets.
Each carton contains 1 or 3 memo-packs. Each
memo-pack contains 21 tablets, which include
11 white tablets and 10 pale brown tablets.
Not all pack sizes may be marketed.
6.3 Marketing Authorisation Holder
Meda Pharmaceuticals Ltd, Skyway House,
Parsonage Road, Takeley, Bishop’s Stortford, CM22
6PU.
6.4 Manufacturer
Bayer Weimer GmbH und Co KG, Weimar,
Dobereinerstrasse 20D-99427, Germany and
Bayer Pharma AG, Berlin, Germany
This leaflet was last updated on March 2012
If this leaflet is difficult to see or read or you
would like it in a different format, please contact
Meda Pharmaceuticals Ltd, Skyway House,
Parsonage Road, Takeley, Bishop’s Stortford,
CM22 6PU.

United Kingdom 80801874

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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